Next week at the United Nations General Assembly High-level Meeting on Universal Health Coverage, global leaders will agree on priorities to drive change for a healthier world. Drafts of the political declaration on UHC recognize the sweeping, cross-sectoral action required to expand UHC and pay particular attention to the need for robust, responsive, and resilient health systems that can support expanded access to health services and medical products.
But the declaration — and the wider effort to expand UHC — falls short in addressing a largely unseen and under-recognized threat that pulls progress toward UHC one step back for every two taken forward; one that can keep patients ill for longer or potentially worsen their condition, squander already scarce financial and human resources, and contribute to the spread of antimicrobial resistance.
In a world in which UHC schemes increase access to quality-assured medical products, we envision a reduction in out-of-pocket expenses, a slowing of the evolution of antimicrobial resistance, and a reduction in wasteful spending and avoidable retreatment costs.—
This often overlooked yet fundamental threat to UHC is the pervasive and persistent presence of poor-quality medical products in clinics and pharmacies throughout the world. In advance of UNGA, new research from the USAID-funded Promoting the Quality of Medicines program shines a light on just how detrimental the continued presence of poor-quality medicines is to UHC.
Holding back progress on UHC
The World Health Organization recently undertook a review of the literature and developed an estimate that 1 in 10 medical products in low- and middle-income countries is of poor-quality. Subsequent reviews support this estimate, and many studies show prevalence can be higher depending on the country and type of medicine.
How can poor-quality medicines be whittled out of the market? President of the Pharmaceutical Society of Nigeria Mazi Sam Ohuabunwa explains why local manufacturing could be one solution.
Any availability of poor-quality medical products can have disastrous effects, and the impact on patients and families extends well beyond poor health outcomes and can lead to additional out-of-pocket health care costs, lost income, and lost productivity. Ultimately, these experiences can undermine the trust people place in medicines and their health systems.
WHO estimates the economic toll of poor-quality medicines in LMICs at $30.5 billion per year, and global estimates range as high as $200 billion annually. That’s billions that could be reinvested to procure additional medicines, extend health services, and expand coverage under UHC schemes.
Estimating the precise impact of poor-quality medicines on a population’s health and national budgets can be challenging. However, new research from the PQM program, with support from the University of North Carolina, provides insight into the dramatic impact that assuring the quality of medical products can have.
Using a model recently developed at UNC, the findings show, for example, that assuring the quality of all antimalarials in Nigeria — where the malaria burden is the highest in the world and where approximately 14% of antimalarials have been found to be of poor-quality — could spare 33,300 Nigerian children under age 5 the trauma of ending up in hospital with severe malaria, and save the lives of 12,300 children every year. That means 33 fewer child deaths every single day. We also estimate that the direct cost savings to the health care system and patients could be as much as $30 million per year in Nigeria alone.
The long-term impact of assuring the quality of antimalarials alone is huge — in this model, children whose lives could be saved by removing poor-quality antimalarials from the market would contribute an estimated $860 million to the Nigerian economy over their lifetimes.
If the cost savings modeled for Nigeria are realized and extrapolated to other essential medicines across LMICs, the impact would be profound.
Assuring the quality of medicines
Despite growing evidence of the problem and its outsized impact on UHC, the effect of poor-quality medicines is rarely raised. But there are proven ways countries can protect patients and make their UHC resources go further.
Mark your calendar. On Tuesday, Sept. 24, Devex is convening a day-long UHC Pavilion on the sidelines of the U.N. General Assembly in New York City, hosting a series of events focused on the critical topic of universal health coverage. Sign up for the livestream on UHC here.
Fundamentally, strengthening medicines regulatory authorities and involving them in UHC conversations so that they are capable of implementing key quality assurance measures in health systems is essential. USAID, WHO, and other partners have been forging the way forward on this front.
Given that resources for regulatory authorities in LMICs are often insufficient to carry out all functions, focusing on building capacity in critical areas in ways that account for greatest risks to public health — such as monitoring the quality of medicines in the marketplace — can also ensure that existing resources will do the greatest amount of good.
The USAID-funded PQM program, implemented by USP, develops guidelines and tools to help LMICs do just that. By supporting countries to implement risk-based approaches to monitor medical product quality, use modern point-of-care medicine quality screening technologies, and bolster national quality control laboratory capacity, programs such as PQM are helping regulatory authorities make the most of their limited resources.
As the pharmaceutical industry and supply-chains become increasingly global and complex, it is also becoming more difficult for regulators, especially those in LMICs, to have robust capacity in specialized and emerging regulatory areas such as bioequivalence, biologics, and production of active ingredients.
Smaller and under-resourced regulators can complement their existing capacity by relying on support from better-resourced, neighboring countries. Efforts toward increased regional reliance and harmonization models are gaining ground. In Africa, the African Union Development Agency — formerly NEPAD — and regional economic communities are making major headway on this front.
While working to keep poor-quality medicines off the market, it is critical to also address supply-side issues, which push many patients to seek treatment in unregulated, informal sectors where the prevalence of poor-quality medicines is likely to be higher. As there are only a handful of manufacturers producing some essential medicines, addressing the issue requires direct private-sector engagement, collaboration, and investment to increase local capacity for good manufacturing practices, and the promotion of technology transfer to improve the supply of medicines for UHC medicines benefit programs.
Stronger regulatory systems can streamline processes for market entry, incentivizing manufacturers to register additional products. Strong regulators are also able to establish therapeutic equivalence between innovator and generic medicines, informing the inclusion of less expensive quality-assured generics on the national formulary. This can lower the costs of medicines so that UHC programs can expand coverage of health services, cover more people, or lower costs for patients.
Achieving the promise of UHC
UHC financing schemes should incentivize the procurement, distribution, and use of medicines through a system that ensures quality; expanding coverage would then increase demand for quality-assured medicines, in a virtuous cycle. In a world in which UHC schemes increase access to quality-assured medical products, we envision a reduction in out-of-pocket expenses, a slowing of the evolution of antimicrobial resistance, and a reduction in wasteful spending and avoidable retreatment costs.
UNGA’s draft political declaration advocates for increased access to “affordable, safe, effective, and quality medicines” and mentions that new legislation and policies should “[foster] awareness about the risks of substandard and falsified medical products, and [assure] the quality and safety of services, products, and practice of health workers.” As we move together to build a healthier world, let’s give quality assurance of medicines the attention and resources it merits.
Read here for more information on integrating medicines quality assurance into UHC programming.